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OpenTrials
Completed

NCT Number: NCT04354688

T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD

This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Jose, Providencia, Santiago Metropolitan, Chile

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About this study

This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:

  • Resistance to countertorque testing (mobility)
  • Implant Stability Quotient (ISQ)
  • Changes in peri-implant crestal bone levels
  • Confirmation of clinical benefits

A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either sex and greater than 18 years of age
  • Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
  • Immediate extraction or a prior extracted site
  • Patients must be physically able to tolerate conventional surgical and restorative procedures.
  • Presence of opposing dentition
  • Patients who provide a signed informed consent.
  • Patients who agree to be evaluated for each study visit.
  • Minimum primary stability, insertion torque > 35Ncm

Exclusion criteria

  • Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
  • Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
  • Patients with active infection or severe inflammation in the areas intended for implant placement.
  • Patients with a > 10 cigarette per day smoking habit.
  • Patients with a history of therapeutic radiation to the head or jaw.
  • Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
  • Patients with evidence of severe parafunctional habits such as bruxing or clenching.
  • Patients with HIV or Hepatitis infection

Treatment and study plan

T3 Certain Tapered Implant

Device

Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)

Primary outcomes

  1. Implant survival

    Time frame: 2 years

    Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement

Secondary outcomes

  1. Peri-implant crestal bone levels

    Time frame: 2 years

    Assessed by radiographic measurements of serial crestal bone levels

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System

Acronym: Apple

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2020
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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